Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)Phase 1NCT05677893

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

A Phase 1 study testing MBS-COV in people with Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder), run by Oneness Biotech Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV in Healthy Participants Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
What is being tested?: MBS-COV
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2022to 30 Mar 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
No serious or chronic underlying disease which would adversely affect the study conduct and data interpretation per the investigator.
Female participants should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission
Participants with normal spirometry (FEV1: 90% or greater) results at screening or day -1.
Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception.
Participants should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement including the hematology, biochemistry, coagulation indices, and urinalysis.

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Participants should have a normal (or abnormal but not clinically significant) 12-lead ECG at screening and day -1 and chest X-ray at screening
Participants should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent.
Current non-smokers and those who have not smoked within the last 3 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
Nasopharyngeal or nasal swab sample of Participants collected for COVID-19 antigen rapid test at screening and qRT-PCR test on Day -1 should be negative.

Who cannot join

The participant has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening.
As reported by the participant has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the participant and might interfere with the study conduct and results interpretation.
The participant has history or presence of active lung disease (i.e., asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation.
The participant has upper respiratory infection within the 3 months prior to the first dose of study drug.
Consumed more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcohol products in the 48 hours prior to administration, or those who have a positive alcohol breath test result at screening and day -1.
Unwillingness to abstain from the consumption of any caffeine or alcohol-containing food or drinks that may influence the drug metabolism from 48 hours before administration.

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History of drug abuse or a positive drug abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) test result at screening and day -1.
Female participants who are lactating.
Use of prescription or non-prescription drugs, including vaccine within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
The subject has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to the first dose of study drug and will receive another experimental agent during the duration of this study.
The participant has a history of frequent nose bleeding.
Participants with known allergic reactions to the study drug or its excipients.
The participant has an acute sinusitis or history of chronic sinusitis, a history of active allergic rhinitis (AR), history of perennial allergic rhinitis (PAR), or current seasonal allergic rhinitis (SAR), or recent viral rhinitis within 2 weeks prior to administration.
The participant has Any nasopharyngeal abnormality that may have interfered with nasal absorption, distribution, or study-related evaluations of signs or symptoms (e.g., polyps, septal deviation).
Blood donation of more than 400 mL within 3 months before screening or more than 200 mL within 4 weeks before screening or plan to donate blood during study period.
Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Phase I Unit
Los Angeles, California, 90630

Other trials in United States

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

Conditions: Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
Being tested: MBS-COV, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MBS-COVDrug
MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.
PlaceboOther
Normal saline

Study groups in NCT05677893
Study group	Role	What they receive
Investigational drug	Experimental	Eligible participants will be assigned to receive 0.3-1.2 mg/kg single or multiple doses of the investigational drug. Receives: Drug: MBS-COV
Placebo	Placebo comparator	Eligible participants will be assigned to single or multiple doses of the placebo. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE
Safety will be reported based on Protocol defined AEs.
For the purpose of this protocol, an AE will be defined as any untoward medical occurrence in a subject during the study.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 202230 Mar 2023

First posted10 Jan 2023
Study start7 Nov 2022
Primary completion30 Mar 2023
Study completion30 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05677893
Sponsor's protocol ID: SNS812CLCT01
Status last verified: Mar 2025
First submitted: 4 Nov 2022
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Chang YC, Chen YF, Yang CF, Ho HJ, Yang JF, Chou YL, Lin CW, Yang PC. Pharmacokinetics and Safety Profile of SNS812, a First in Human Fully Modified siRNA Targeting Wide-Spectrum SARS-CoV-2, in Healthy Subjects. Clin Transl Sci. 2025 Mar;18(3):e70202. doi: 10.1111/cts.70202.
PubMed 40116355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
ClinicalTrials.gov ID: NCT05677893
Acronym / sponsor ID: SNS812CLCT01
Conditions: Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Nov 2022 (actual)
Primary completion: 30 Mar 2023 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 10 Jan 2023 (actual)
Results: Posted 30 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Investigational drug	Experimental	Drug: MBS-COVEligible participants will be assigned to receive 0.3-1.2 mg/kg single or multiple doses of the investigational drug.
Placebo	Placebo comparator	Other: PlaceboEligible participants will be assigned to single or multiple doses of the placebo.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
No serious or chronic underlying disease which would adversely affect the study conduct and data interpretation per the investigator.
Female participants should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission
Participants with normal spirometry (FEV1: 90% or greater) results at screening or day -1.
Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception.

Key exclusion criteria (16 listed)

The participant has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening.
As reported by the participant has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the participant and might interfere with the study conduct and results interpretation.
The participant has history or presence of active lung disease (i.e., asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation.
The participant has upper respiratory infection within the 3 months prior to the first dose of study drug.
Consumed more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcohol products in the 48 hours prior to administration, or those who have a positive alcohol breath test result at screening and day -1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MBS-COVMBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Drug	Investigational drug
PlaceboNormal saline	Other	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE
Time frame: 1 month
Safety will be reported based on Protocol defined AEs. For the purpose of this protocol, an AE will be defined as any untoward medical occurrence in a subject during the study.

Results and safety

Results posted to the registry on 30 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Drug, 0.3 mg/kg, Part A (SAD)	6	5
Investigational Drug, 0.6 mg/kg, Part A (SAD)	6	6
Investigational Drug, 1.2 mg/kg, Part A (SAD)	6	6
Placebo, Part A (SAD)	6	6
Investigational Drug, 0.6 mg/kg, Part B (MAD)	8	7
Investigational Drug, 1.2 mg/kg, Part B (MAD)	8	7
Placebo, Part B (MAD)	4	4

Primary outcome: Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Investigational Drug, 0.3 mg/kg, Part A (SAD) n = 6	Investigational Drug, 0.6 mg/kg, Part A (SAD) n = 6	Investigational Drug, 1.2 mg/kg, Part A (SAD) n = 6	Placebo, Part A (SAD) n = 6	Investigational Drug, 0.6 mg/kg, Part B (MAD) n = 8	Investigational Drug, 1.2 mg/kg, Part B (MAD) n = 8	Placebo, Part B (MAD) n = 4
Value	3	0	0	1	0	2	0

Adverse events

Time frame: From start of treament on Day 1 to Day 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Drug, 0.3 mg/kg, Part A (SAD)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Investigational Drug, 0.6 mg/kg, Part A (SAD)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Investigational Drug, 1.2 mg/kg, Part A (SAD)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Placebo, Part A (SAD)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Investigational Drug, 0.6 mg/kg, Part B (MAD)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Investigational Drug, 1.2 mg/kg, Part B (MAD)	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Placebo, Part B (MAD)	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40116355Chang YC, Chen YF, Yang CF, Ho HJ, Yang JF, Chou YL, Lin CW, Yang PC. Pharmacokinetics and Safety Profile of SNS812, a First in Human Fully Modified siRNA Targeting Wide-Spectrum SARS-CoV-2, in Healthy Subjects. Clin Transl Sci. 2025 Mar;18(3):e70202. doi: 10.1111/cts.70202.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MBS-COV in people with Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder), run by Oneness Biotech Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.